Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126191481 | 12619148 | 1 | I | 20160719 | 20160803 | 20160803 | EXP | CA-HQ SPECIALTY-CA-2016INT000660 | INTERCHEM | 57.00 | YR | F | Y | 0.00000 | 20160803 | CN | CA | CA |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126191481 | 12619148 | 1 | PS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | 2.8571 MG (20 MG,1 IN 1 W) | N | 201749 | 20 | MG | ||||||||
| 126191481 | 12619148 | 2 | SS | ENBREL | ETANERCEPT | 1 | Subcutaneous | 50 MG, 1 W | N | 0 | 50 | MG | |||||||
| 126191481 | 12619148 | 3 | SS | SULFASALAZINE. | SULFASALAZINE | 1 | Oral | 2 G (1 G,2 IN 1 D) | N | 0 | 1 | G | |||||||
| 126191481 | 12619148 | 4 | SS | PLAQUENIL /00072602/ | HYDROXYCHLOROQUINE DIPHOSPHATE | 1 | 400 MG, 1 D | N | 0 | 400 | MG | ||||||||
| 126191481 | 12619148 | 5 | SS | ARAVA | LEFLUNOMIDE | 1 | 20 MG, 1 D | N | 0 | 20 | MG | ||||||||
| 126191481 | 12619148 | 6 | SS | HUMIRA | ADALIMUMAB | 1 | 2.8571 MG (40 MG,1 IN 2 W) | N | 0 | 40 | MG | ||||||||
| 126191481 | 12619148 | 7 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | TAPERING DOWN | 0 | ||||||||||
| 126191481 | 12619148 | 8 | SS | PREDNISONE. | PREDNISONE | 1 | DOSE INCREASED | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126191481 | 12619148 | 1 | Rheumatoid arthritis |
| 126191481 | 12619148 | 2 | Rheumatoid arthritis |
| 126191481 | 12619148 | 3 | Rheumatoid arthritis |
| 126191481 | 12619148 | 4 | Rheumatoid arthritis |
| 126191481 | 12619148 | 5 | Rheumatoid arthritis |
| 126191481 | 12619148 | 6 | Rheumatoid arthritis |
| 126191481 | 12619148 | 7 | Rheumatoid arthritis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126191481 | 12619148 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126191481 | 12619148 | Drug ineffective | |
| 126191481 | 12619148 | Drug intolerance | |
| 126191481 | 12619148 | Fatigue | |
| 126191481 | 12619148 | Gastrointestinal disorder | |
| 126191481 | 12619148 | Rheumatoid arthritis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 126191481 | 12619148 | 1 | 20100323 | 201208 | 0 | |
| 126191481 | 12619148 | 2 | 20141216 | 20150615 | 0 | |
| 126191481 | 12619148 | 3 | 201009 | 201009 | 0 | |
| 126191481 | 12619148 | 4 | 201003 | 201009 | 0 | |
| 126191481 | 12619148 | 5 | 201309 | 20150330 | 0 | |
| 126191481 | 12619148 | 6 | 20150615 | 20151103 | 0 |